INNOVASIVE ARTHROSCOPIC ROC SUTURE BONE FASTENER— 510(k) K941273

Substantially Equivalent

Innovasive Devices, Inc.

FDA 510(k) clearance K941273 for INNOVASIVE ARTHROSCOPIC ROC SUTURE BONE FASTENER, Substantially Equivalent on 1994-09-16. Applicant: Innovasive Devices, Inc..

Clearance details

Applicant: Innovasive Devices, Inc.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 1994-03-16
Decision date: 1994-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hopkinton, MA, US

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Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.